TOTAL CHOLESTEROL TEST KIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-08 for TOTAL CHOLESTEROL TEST KIT * manufactured by Biosafe Diagnostic Products, Inc..

Event Text Entries

[242521] The ebiosafe cholesterol kit is labeled as "ouchless" and "painless" this is a misrepresentation. The lancet they use is not ouchless or painless.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024125
• MDR Report Key: 378364
• Date Received: 2002-02-08
• Date of Report: 2002-02-08
• Date Added to Maude: 2002-02-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TOTAL CHOLESTEROL TEST KIT
• Generic Name: CHOLESTEROL TEST
• Product Code: NFX
• Date Received: 2002-02-08
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 367403
• Manufacturer: BIOSAFE DIAGNOSTIC PRODUCTS, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-02-08